NCT00124176

Brief Summary

This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis

  • Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol. Secondary hypotheses
  • Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol.
  • Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

March 14, 2013

Completed
Last Updated

March 14, 2013

Status Verified

December 1, 2012

Enrollment Period

1.8 years

First QC Date

July 25, 2005

Results QC Date

July 14, 2010

Last Update Submit

February 12, 2013

Conditions

Asthma

Keywords

AsthmaLevalbuterolAlbuterolChildren

Outcome Measures

Primary Outcomes (1)

  • Duration of Continuous Therapy

    standard intention to treat (ITT) analysis

    During hospitalization

Secondary Outcomes (4)

  • Change in Pediatric Asthma Severity Score

    After 12 hours of continuous nebulization

  • Heart Rate

    After 12 hours of continuous nebulization

  • Serum Potassium Levels

    After 12 hours of continuous nebulization

  • Serum Albuterol S Isomer Levels

    After 6 hours of continuous albuterol

Study Arms (2)

1

EXPERIMENTAL

Nebulized levalbuterol 10mg/hr given continuously

Drug: Levalbuterol (R albuterol)

2

ACTIVE COMPARATOR

Racemic albuterol 20mg/hr given continuously

Drug: Racemic albuterol (R+S albuterol)

Interventions

Racemic albuterol (R+S albuterol)DRUG

20mg/hr continuous racemic albuterol

2
Levalbuterol (R albuterol)DRUG

10mg/hr continuous nebulized levalbuterol

Also known as: Xopenex
1

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 6-18 years of age
  • Diagnosis of asthma with two previous visits to emergency department (ED) or primary care provider for asthma care
  • Clinical decision by ED attending physician to begin continuous albuterol after standardized initial ED treatment.

You may not qualify if:

  • Clinical decision to begin continuous intravenous beta-agonist infusion (e.g. terbutaline)
  • Clinical decision to admit to the Pediatric Intensive Care Unit
  • Drug allergy or other contraindication to RAC or LEV
  • Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac disease
  • Pregnancy
  • Prior enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Levalbuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Results Point of Contact

Title
Joseph Zorc, MD
Organization
Children's Hospital of Philadelphia
zorc@email.chop.edu
215-590-1944

Study Officials

  • Joseph J Zorc, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2005

First Posted

July 27, 2005

Study Start

April 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

March 14, 2013

Results First Posted

March 14, 2013

Record last verified: 2012-12

Locations

US(1)